Food and Drug Law Commons^™

If It Looks Like A Duck: Equal Protection, Selective Prosecution, And Geographic Differences In The Federal Prosecution Of Marijuana Crimes Under The Controlled Substances Act, Zachary Nelson

Lewis & Clark Law Review

State legalization of marijuana for medical purposes has skyrocketed since California first authorized medical marijuana in 1996. Today, citizens in 33 states can use marijuana for medical purposes. While each state maintains distinct regulatory systems and eligibility requirements, the core result of these state medical marijuana programs is that citizens in 33 states can lawfully possess and use marijuana. Yet federal law makes any use of marijuana illegal under the Controlled Substances Act (CSA). Through the Supremacy Clause, this illegality is controlling and preemptive in every state; that is, even if a state makes marijuana legal for certain purposes, an …

Cannabis Law, The Constitution, And The Aba Model Rules, Hayley Hollis

Lewis & Clark Law Review

Though a growing number of states have legalized recreational or medical cannabis use, cannabis is still categorized as a Schedule I substance under the Controlled Substances Act, and its use, possession, and cultivation are federal offenses. This conflict between state and federal law creates a unique challenge for the legal community. Unless states with legalized cannabis programs have amended their state rules of professional conduct or provided advisory opinions on the matter, local attorneys assume a great deal of risk when representing clients within the cannabis industry.

To further complicate matters, what happens when a lawyer, who is licensed to …

A Hybrid Approach To Marijuana Federalism, Susan F. Mandiberg

Lewis & Clark Law Review

With the evident indulgence of the United States Department of Justice, states are jumping on the bandwagon of legalizing medicinal and recreational marijuana even though marijuana use is criminalized under the Federal Controlled Substances Act. The possibility that the federal government will at some point decriminalize marijuana use poses a challenge for the construction of a regulatory framework. In short, how should the states and the federal government divide regulatory responsibilities?

There has been significant academic discussion about possible regulatory frameworks to address this issue. Drawing upon existing federalism schemes in the environmental and natural resource area, this Article reviews …

Reefer Madness In Federal Court: An Overview Of How Federal Courts Are Dealing With Cannabis Litigation And Why It Is Necessary To “Dig Into The Weeds”, Blake Marvis

Lewis & Clark Law Review

Litigation stemming from the state-legal cannabis industry has presented many unique questions for federal courts to grapple with. Can federal courts provide equitable relief to state-legal cannabis litigants, despite being in violation of federal law? Can workers in the state-legal cannabis industry sue their employers to recover required minimum wage under federal statutes? Is a contract that is made in a state-legal cannabis market automatically void? This Comment examines the precarious nature of state-legal cannabis litigation in federal courts through a dissection of how litigation has progressed. It also examines the framing of the arguments made in cannabis disputes. Although …

Cannabis And Insurance, Francis J. Mootz Iii, Jason Horst

Lewis & Clark Law Review

Although many states have decriminalized or legalized cannabis, it remains a Schedule 1 drug under the federal Controlled Substances Act. The conflict between federal and state law presents many complicated issues, including problems relating to insurance coverage. Insurance law seeks to balance competing policy interests. On one hand, public policy supports reading insurance policies broadly to indemnify policyholders for their losses. On the other hand, public policy counsels against permitting insurance to indemnify (federally) illegal activity. In this Article, we explore some pressing issues arising from the conflict between these policy considerations and offer some analysis of the conflict in …

Craft Beer And The Rising Tide Effect: An Empirical Study Of Sharing And Collaboration Among Seattle's Craft Breweries, Zahr K. Said

Lewis & Clark Law Review

This qualitative empirical research project studies Seattle’s craft brewing industry as a thriving entrepreneurial ecosystem that displays widespread collaboration and innovation. Drawing on data collected in 22 face-to-face formal interviews conducted with industry participants, the Article explores the community’s attitudes, practices, and norms with respect to collaboration and intellectual property (IP). It joins a growing body of qualitative empirical IP scholarship that maps misalignments between law and practice “on the ground,” seeking to offer a more accurate and pluralistic account of an innovative industry. The craft brewing community in Seattle cooperates extensively while continuing to compete actively for consumers. In …

Greater Uniformity And Centralization: The Regulatory Development Of Chinese Food And Product Safety Under The Wto, Nga Kit (Christy) Tang

Washington International Law Journal

The WTO Agreements emphasize free trade, which links with diversity, deregulation, and decentralization. China, on the other hand, emphasizes uniformity and centralization, especially regarding the political control and the one-party system of “democratic dictatorship.” China’s joining the WTO, therefore, may be considered as a development that changes the regulatory structure to become more diverse, deregulated, and decentralized. This paper, however, finds the opposite. Under the WTO law, China is encouraged to move towards greater uniformity and centralization with its decentralized and non-uniform settings under the market policy. Moreover, the WTO’s uniform and centralized encouragements can be integrated into the rule-by-man …

Regulatory Gaps In Drug Compounding: Implications For Patient Safety, Innovation, And Fraud, Joanna Shepherd

Faculty Articles

Drug compounding is the practice of mixing, combining, or altering drug ingredients to create a product that meets the medical needs of a patient whose needs cannot otherwise be met with commercially-available products. Compounding is essential for patients that are allergic to certain ingredients or cannot tolerate the route of administration or dosage form of a commercially-available drug. Compounding may also enable pharmacists to supply medications when there is a shortage of commercially-available drugs. For example, amid the nationwide shortage of generic liquid Tamiflu and growing flu deaths in early 2018, pharmacists around the country used Tamiflu capsules to compound …

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.

Fraud, Abuse, And Opioids, Stacey A. Tovino

Faculty Articles

This Article analyzes recent government enforcement actions involving two health care fraud and abuse authorities, including the federal Anti- Kickback Statute and the federal civil False Claims Act, in cases involving opioids. Part II of this Article examines recent government enforcement actions involving the federal Anti-Kickback Statute, which prohibits (among other conduct) the exchange of remuneration for opioid prescriptions, patient referrals for drug testing services, and patient referrals for addiction treatment services if such prescriptions or services are reimbursed in whole or in part by a federal health care program. Part III of this Article examines recent government enforcement actions …

Commercial Speech Protection As Consumer Protection, Felix T. Wu

Articles

The Supreme Court has long said that “the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides.” In other words, consumers—the recipients or listeners of commercial speech—are the ones the doctrine is meant to protect. In previous work, I explored the implications of taking this view seriously in three contexts: compelled speech, speech among commercial entities, and unwanted marketing. In each of those contexts, adopting a listener-oriented approach leads to the conclusion that many forms of commercial speech regulation should receive far less First Amendment scrutiny than …

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …

The Surprising Reach Of Fda Regulation Of Cannabis Even After Rescheduling, Sean M. O'Connor, Erika Lietzan

Articles

As more states legalize cannabis, the push to “deschedule” it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis—cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA’s focus on precise analytical characterization and on individual active and inactive ingredients may be fundamentally inconsistent …

Life, Liberty, [And The Pursuit Of Happiness]: Medical Marijuana Regulation In Historical Context, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

The struggle for access to medical marijuana differs from most other battles for therapeutic freedom in American history because marijuana also has a popular, though controversial, nontherapeutic use—delivery of a recreational high. After considering struggles over the medical use of alcohol during prohibition as a precedent, this chapter relates the history of medical marijuana use and regulation in the United States. The bulk of the chapter focuses on the medical marijuana movement from the 1970s to present. This campaign has been one of the prime examples of a successful extrajudicial social movement for freedom of therapeutic choice. With the exception …

The Orphan Drug Act At 35: Observations And An Outlook For The Twenty-First Century, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite

Articles

On the thirty-fifth anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new orphan drugs appears to be greater today than it was in 1983. All else equal, this should reduce the threshold for research and development (R&D) investment in an economically viable product. Further, the small size of patient populations for orphan drugs, together with the increasing prevalence of biologics among orphan drugs, have created a set …

The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers

Barry Law Review

No abstract provided.

On Opioids And Erisa: The Urgent Case For A Federal Ban On Discretionary Clauses, Katherine T. Vukadin

University of Richmond Law Review

The American opioid epidemic cuts across all social divisions, touching the employed and unemployed. Those with private health insurance are one of the fastest-growing affected groups, but this group struggles most to get care. Despite their insured status, the privately-insured received treatment at half the rate of those with Medicaid and at even lower rates than the uninsured. This article focuses on a significant barrier to treatment for those in employer sponsored benefit plans: the discretionary clause. A discretionary clause grants the decision maker broad latitude and ensures that any federal court review is deferential. Claims processing in such a …

Encouraging Food Safety Standard Negotiations In The One-Belt-One-Road Initiative, Yi Seul Kim

Cardozo International & Comparative Law Review

Participation and attendance in food safety negotiations such as Codex meetings are of critical importance. Common problems have existed throughout history in the area of food safety standards and their formulation regulations. First, there is a lack of interest by the public. Second, the public becomes interested only after a food safety crisis. Consequences are two-fold: with lack of public interest, governments often do not allocate enough budget and resources. Then, when the government turns to face the problem with a sudden spike in public interest, it is often too late. The situation becomes more of a crisis management, rather …

Redefining "Life": The Constitutional Implications Of Patenting Immortality, Julia Spivak

Cardozo Arts & Entertainment Law Journal

No abstract provided.

A Case For United States Overhaul Of Its Current Biotechnology Regulation Scheme Through The Implementation Of Biotechnology-Specific Legislation To Clarify Existing Uncertainties Seen In The Collective Framework, Jordan Emmert

Cardozo International & Comparative Law Review

The U.S. biotechnology regulatory framework, established by the 1986 Coordinated Framework and its 1992 Update, is outdated and insufficient to address modern biotechnology products, particularly genetically modified organisms (GMOs). While efforts such as the Obama Administration’s 2015 Memorandum and the 2016 Update aimed to modernize the system, they failed to resolve jurisdictional ambiguities and regulatory gaps, leading to inconsistent agency enforcement and public distrust. The note argues that updating the statutory framework is essential to align U.S. regulations with international norms, ensure public safety, and maintain global competitiveness.

Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle

Scholarly Articles in Law Reviews & Journals

Legal scholars are becoming increasingly interested in how the literature on implicit bias helps explain illegal discrimination. However, these scholars have not yet mined all of the insights that science on the social brain can offer antidiscrimination law. That science, which researchers refer to as social neuroscience, involves a broadly interdisciplinary approach anchored in experimental natural science methodologies. Social neuroscience shows that the brain tends to evaluate others by distinguishing between "us" versus "them" on the basis of often insignificant characteristics, such as how people dress, sing, joke, or otherwise behave. Subtle behavioral markers signal social identity and group membership, …

Drug Prices, Dying Patients, And The Pharmaceutical Marketplace: A New Conditional Approval Pathway For Critical Unmet Medical Needs, Robert A. Bohrer

Faculty Scholarship

Prescription drugs have been a major topic in the news for much of the past year. There are two issues which appear often: first, the very high prices of new drugs, particularly the "specialty" drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both issues, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs, and for insurance companies and the government …

Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer

Faculty Scholarship

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads …

Direct-To-Consumer Calls To Action: Lowering The Volume Of Claims And Disclosures In Prescription Drug Broadcast Advertisements, Andrew Andrzejewski

Brooklyn Law Review

Pharmaceutical companies advertise drugs directly to consumers via television and radio broadcast commercials, print advertisements, and the internet. Although broadcast advertisements are demonstrably unable to adequately convey risk information, a total ban on them would be too restrictive, and any regulation targeting these advertisements must withstand First Amendment scrutiny. The FDA’s recent attempts to modify its requirements for broadcast advertisements do not overcome these challenges. It is in the best interest of patients, doctors, the drug industry, and the government for Congress to authorize the FDA to regulate broadcast drug advertisements as limited calls to action, consisting of restricted product …

Federalization's Folly, Stephen F. Smith

Journal Articles

Overcriminalization and overpunishment are the two key features of federal criminal law today, yet the constant drumbeat to “federalize” criminal law has accomplished precious little in terms of public safety. The failed drug war proves as much: federal prosecutors have filled the nation’s prisons with low-level drug dealers and drug users serving long sentences, but drugs remain widely available at greater purity and lower prices throughout the land — and drug overdoses are at record highs. Instead of focusing on areas of federal comparative advantage, such as terrorism, international drug trafficking, and organized crime, federal prosecutors waste scarce resources “playing …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

The Carbon Tax Vacuum And The Debate About Climate Change Impacts: Emission Taxation Of Commodity Crop Production In Food System Regulation, Gabriela Steier

Pace Environmental Law Review

The scientific consensus on climate change is far ahead of U.S. policy on point. In fact, the U.S. has a legal vacuum of carbon taxation while climate change continues to impact the codependence of agriculture and the environment. As this Article shows, carbon taxes follow the polluter-pays model, levying taxes on the highest greenhouse gas (“GHG”) emissions—and contributions to climate change. But this is not only unsustainable; it would also undermine agricultural production and, thus, food security. This Article describes how the law can regulate climate change contributions and promote adaptation and mitigation supported through carbon taxes in the agricultural …

Food Sustainability In The Age Of Complex, Global Supply Chains, Steph Tai

Arkansas Law Review

Food production has become more complex over time. Moreover, we are producing food in an increasingly global, rather than local, manner. How can demands for sustainability be reinforced in this age of complex, global supply chains? This essay focuses on three key features of the modern food supply chain: the variety of components, the complexity of the chain itself, and diversity of “enforcement” mechanisms in food production supply chains. These features suggest that traditional governmental tools (such as command and control measures) and contractual tools (such as performance standards) may not be sufficient to ensure sustainable production methods.

Unrealistic Expectations: The Federal Government's Unachievable Mandate For State Cannabis Regulation, Rebecca Sweeney

Washington Law Review

The states that have legalized cannabis maintain a complicated relationship with the federal government. Since the Ogden Memorandum was issued in 2009, the federal government has left regulation of cannabis to the discretion of the states. That policy has recently shifted. In 2018, former U.S. Attorney General Jeff Sessions issued a new memorandum that rescinded guidance for states about how to structure the legalization of cannabis. The federal government’s current position is now ideologically aligned with that of states like Nebraska and Oklahoma. These states chose not to legalize cannabis and instead adhere to the Controlled Substances Act’s classification of …

Super Unleaded Malbec? A Case Study In Flawed International Standard Setting At The Codex Alimentarius, Justin Schwegel

Journal of Food Law & Policy

The World Trade Organization’s (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) provides rules on the adoption and enforcement of SPS measures. It also presumes that food safety regulations adopted by WTO Members that conform to relevant international standards are consistent with the SPS Agreement. The relevant international standard setting body for food safety is the Codex Alimentarius Commission, which conducts most of its food safety risk management work through subsidiary bodies such as the Codex Committee on Contaminants in Food (CCCF). CCCF establishes maximum limits for food contaminants and codes of practice for reducing food …